NUTRIBRAIN: Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice (POWER)

NCT07462013 | Recruiting DMC

• 1 other identifier: CMUH114-REC3-136
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

POWER project is a randomized, controlled, non-profit study with the primary objective of testing the effectiveness of non-pharmacological interventions-such as physical activity, cognitive training, and dietary supplementation-in reducing depressive symptoms and preventing or delaying cognitive impairments that frequently co-occur in individuals with Major Depressive Disorder (MDD).

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (9)

• Depressive Symptoms

  The 17-item version (HAMD-17) is used to quantify the severity of depression. A score of ≥18 shows a significant depression level.

  Weeks 0, 4, 8, 12, 16, 24

• Depressive Symptoms

  The GDS-15 (15-item Geriatric Depression Scale), a score of 5 or higher (≥5) indicates the presence of depression, or "clinically relevant" depressive symptoms.

  Weeks 0, 4, 8, 12, 16, 24

• Depressive Symptoms

  The 20-item Center for Epidemiological Studies Depression Scale (CES-D) to indicate significant, or "clinical," depressive symptoms is a total score higher than or equal to 16.

  Weeks 0, 4, 8, 12, 16, 24

• Depressive Symptoms

  The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale with a total score range of 0 to 60, where higher scores indicate more severe depression.

  Weeks 0, 4, 8, 12, 16, 24

• Executive Functioning

  The Trail Making Test (TMT) evaluates cognitive impairment by measuring the time (in seconds) to complete tasks. Higher scores indicate slower, more impaired performance.

  Weeks 0, 4, 12, 24

• Executive Functioning

  Based on clinical literature, the Reliable Digit Span (RDS)-a raw score sum of the longest string of digits recalled forward and backward-is a common embedded measure of executive functioning and performance validity. Below 7 indicates a need for caution regarding the validity of the patient's cognitive effort or indicates a potential decline in working memory/attention.

  Weeks 0, 4, 12, 24

• Executive Functioning

  The Modified Wisconsin Card Sorting Test (M-WCST) assesses executive functioning, with higher scores indicating greater dysfunction or impairment.

  Weeks 0, 4, 12, 24

• General Cognitive Ability and Memory & Attention

  The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) uses age-corrected index scores (Mean=100, SD=15) to identify cognitive impairment. Cutoff points for identifying impairment are set at 1 or 1.5 standard deviations (SD) below the mean.

  Weeks 0, 4, 12, 24

• Processing Speed

  Commonly used cut-off points for identifying cognitive impairment using the Digit Symbol Substitution Test (DSST) often fall within the range of lower than or equal to 25-35 points.

  Weeks 0, 4, 12, 24

Secondary Outcomes (2)

• Gut microbiome composition

  Weeks 0 and 24

• Fatty Acids Profiles in Blood

  Weeks 0 and 24

Study Arms (2)

Eicosapentaenoic Acid (EPA)

EXPERIMENTAL

3 gram/day

Dietary Supplement: Eicosapentaenoic acid (omega-3 fatty acid)

Placebo

PLACEBO COMPARATOR

Soy Bean Oil, 3 gram/day

Dietary Supplement: Soybean oil (Standard treatment)

Interventions

Soybean oil (Standard treatment) DIETARY_SUPPLEMENT

3g/day of Soybean Oil

Placebo

Eicosapentaenoic acid (omega-3 fatty acid) DIETARY_SUPPLEMENT

3 grams/day

Eicosapentaenoic Acid (EPA)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50-80 years old
• Major Depressive Disorder
• Absence or mild cognitive impairment

Sponsors & Collaborators

• National Science and Technology Council, Taiwan: lead
• IRCCS Centro San Giovanni di Dio Fatebenefratelli: collaborator
• University College Cork: collaborator

Study Sites (1)

Mind Body Interface Research Center (MBI Lab & Care)

Taichung, Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Soybean Oil; Eicosapentaenoic Acid; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to one of two groups: 1) soybean oil placebo, 2) omega-3 PUFA supplementation (3g/day of eicosapentaenoic acid (EPA)).

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 10, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

TW (1)